• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement
Regulation Description Nonabsorbable expanded polytetrafluoroethylene surgical suture.
Definition To repair or replace chordae tendinae.
Product CodePAW
Regulation Number 878.5035
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure To Adhere Or Bond 1 1
Disconnection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 1 1
Mitral Regurgitation 1 1
Regurgitation, Valvular 1 1
Mitral Valve Prolapse 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 On-X Life Technologies, Inc. II Jan-20-2017
-
-